Ampicillin

Ampicillin Sodium


Sandoz Inc
Human Prescription Drug
NDC 0781-9242
Ampicillin also known as Ampicillin Sodium is a human prescription drug labeled by 'Sandoz Inc'. National Drug Code (NDC) number for Ampicillin is 0781-9242. This drug is available in dosage form of Injection, Powder, For Solution. The names of the active, medicinal ingredients in Ampicillin drug includes Ampicillin Sodium - 250 mg/1 . The currest status of Ampicillin drug is Active.

Drug Information:

Drug NDC: 0781-9242
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Ampicillin
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Ampicillin Sodium
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Sandoz Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Powder, For Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:AMPICILLIN SODIUM - 250 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRAMUSCULAR
INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 03 Mar, 1971
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA061395
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Sandoz Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1721473
1721474
1721475
1721476
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:JFN36L5S8K
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Penicillin-class Antibacterial [EPC]
Penicillins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0781-9242-9510 VIAL, GLASS in 1 PACKAGE (0781-9242-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-9242-78)28 Apr, 2015N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Ampicillin ampicillin sodium ampicillin sodium ampicillin ampicillin ampicillin sodium ampicillin sodium ampicillin ampicillin ampicillin sodium ampicillin sodium ampicillin ampicillin ampicillin sodium ampicillin sodium ampicillin

Drug Interactions:

Drug interactions the concurrent administration of allopurinol and ampicillin increases substantially the incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. it is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

Indications and Usage:

Indications and usage ampicillin for injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: respiratory tract infections caused by streptococcus pneumoniae . staphylococcus aureus (penicillinase and nonpenicillinase-producing), h. influenzae, and group a beta-hemolytic streptococci. bacterial meningitis caused by e. coli, group b streptococci , and other gram-negative bacteria ( listeria monocytogenes, n. meningitidis ). the addition of an aminoglycoside with ampicillin may increase its effectiveness against gram-negative bacteria. septicemia and endocarditis caused by susceptible gram-positive organisms including streptococcus spp., penicillin g-susceptible staphylococci , and enterococci . gram-negative sepsis caused by e. coli, proteus mirabilis and salmonella spp. responds to ampicillin. endocarditis due to enterococcal strains usually respond to intravenous therapy. the addition of an aminoglycos
ide may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. urinary tract infections caused by sensitive strains of e. coli and proteus mirabilis. gastrointestinal infections caused by salmonella typhi (typhoid fever), other salmonella spp., and shigella spp. (dysentery) usually respond to oral or intravenous therapy. bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. therapy may be instituted prior to obtaining results of susceptibility testing. it is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. a change to oral ampicillin may be made as soon as appropriate. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection and other antibacterial drugs, ampicillin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. indicated surgical procedures should be performed.

Warnings:

Warnings serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. these reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. there have been well-documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with a cephalosporin. before initiating therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. if an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted. serious anaphylactoid reactions require immediate emergency treatment with epinephrine, oxygen, intravenous steroid
s, and airway management, including intubation, should also be administered as indicated. clostridium difficile associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including ampicillin for injection, and may range in severity from mild diarrhea to fatal colitis. treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of c. difficile . c. difficile produces toxins a and b which contribute to the development of cdad. hypertoxin producing strains of c. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. cdad must be considered in all patients who present with diarrhea following antibiotic use. careful medical history is necessary since cdad has been reported to occur over two months after the administration of antibacterial agents. if cdad is suspected or confirmed, ongoing antibiotic use not directed against c. difficile may need to be discontinued. appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of c. difficile , and surgical evaluation should be instituted as clinically indicated.

General Precautions:

General the possibility of superinfections with mycotic organisms or bacterial pathogens should be kept in mind during therapy. in such cases, discontinue the drug and substitute appropriate treatment. a high percentage (43 to 100 percent) of patients with infectious mononucleosis who receive ampicillin develop a skin rash. typically, the rash appears 7 to 10 days after the start of oral ampicillin therapy and remains for a few days to a week after the drug is discontinued. in most cases, the rash is maculopapular, pruritic, and generalized. therefore, the administration of ampicillin is not recommended in patients with mononucleosis. it is not known whether these patients are truly allergic to ampicillin. prescribing ampicillin for injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Dosage and Administration:

Dosage and administration infections of the respiratory tract and soft tissues. patients weighing 40 kg (88 lbs) or more: 250 mg to 500 mg every 6 hours. patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals. infections of the gastrointestinal and genitourinary tracts (including those caused by neisseria gonorrhoeae in females). patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours. patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals. in the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. smaller doses than those recommended above should not be used. higher doses should be used for stubborn or severe infections. in stubborn infections, therapy may be required for several weeks. it may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation o
f therapy. urethritis in males due to n. gonorrhoeae. adults – two doses of 500 mg each at an interval of 8 to 12 hours. treatment may be repeated if necessary or extended if required. in the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. in all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. the doses for the preceding infections may be given by either the intramuscular or intravenous route. a change to oral ampicillin may be made when appropriate. bacterial meningitis adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) the doses for other infections may be given by either the intravenous or intramuscular route. neonates (less than or equal to 28 days of postnatal age) - dosage should be based on gestational age and postnatal age according to table 1. table 1: dosage in neonates (less than or equal to 28 days of postnatal age) for bacterial meningitis and septicemia gestational age (weeks) postnatal age (days) dosage less than or equal to 34 less than or equal to 7 100 mg/kg/day in equally divided doses every 12 hours less than or equal to 34 greater than or equal to 8 and less than 28 150 mg/kg/day in equally divided doses every 12 hours greater than 34 less than or equal to 28 150 mg/kg/day in equally divided doses every 8 hours septicemia adults and children – 150 to 200 mg/kg/day. start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours. neonates (less than or equal to 28 days of postnatal age) - dosage should be based on gestational age and postnatal age according to table 1 (above). treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. a minimum of 10 days treatment is recommended for any infection caused by group a beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

Contraindications:

Contraindications a history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

Adverse Reactions:

Adverse reactions as with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. they are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. the following adverse reactions have been reported as associated with the use of ampicillin: gastrointestinal glossitis, stomatitis, black “hairy” tongue, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. (these reactions are usually associated with oral dosage forms.) hypersensitivity reactions skin rashes and urticaria have been reported frequently. a few cases of exfoliative dermatitis and erythema multiforme have been reported. anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form. note: urticaria, other skin rashes, and serum sickness-like reactions may be controlled
with antihistamines and, if necessary, systemic corticosteroids. whenever such reactions occur, ampicillin should be discontinued, unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to ampicillin therapy. serious anaphylactic reactions require the immediate use of epinephrine, oxygen, and intravenous steroids. liver – a moderate rise in serum glutamic oxaloacetic transaminase (sgot) has been noted, particularly in infants, but the significance of this finding is unknown. mild transitory sgot elevations have been observed in individuals receiving larger (two to four times) than usual and oft-repeated intramuscular injections. evidence indicates that glutamic oxaloacetic transaminase (got) is released at the site of intramuscular injection of ampicillin sodium and that the presence of increased amounts of this enzyme in the blood does not necessarily indicate liver involvement. hemic and lymphatic systems – anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with the penicillins. these reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. central nervous system - seizures

Drug Interactions:

Drug interactions the concurrent administration of allopurinol and ampicillin increases substantially the incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. it is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

Pediatric Use:

Pediatric use guidelines for the administration of these drugs to children, including neonates are presented in dosage and administration section.

Overdosage:

Overdosage in cases of overdose, discontinue medication, treat symptomatically, and institute supportive measures as required. in patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not peritoneal dialysis.

Description:

Description ampicillin for injection, usp the monosodium salt of [2s-[2α,5α,6β(s*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. it is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible gram-positive organisms and many common gram-negative pathogens. ampicillin for injection, usp is a white to cream-tinged, crystalline powder. the reconstituted solution is clear, colorless and free from visible particulates. each vial of ampicillin for injection, usp contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. ampicillin for injection, usp contains 65.8 mg [2.9 meq] sodium per gram ampicillin. it has the following molecular structure: the molecular formula is c 16 h 18 n 3 nao 4 s, and the molecular weight is 371.39. the ph range of the reconstituted solution is 8 to 10. chemical-structure

Clinical Pharmacology:

Clinical pharmacology ampicillin for injection diffuses readily into most body tissues and fluids. however, penetration into the cerebrospinal fluid and brain occurs only when the meninges are inflamed. ampicillin is excreted largely unchanged in the urine and its excretion can be delayed by concurrent administration of probenecid. due to maturational changes in renal function, ampicillin half-life decreases as postmenstrual age (a sum of gestational age and postnatal age) increases for infants with postnatal age of less than 28 days. the active form appears in the bile in higher concentrations than those found in serum. ampicillin is the least serum-bound of all the penicillins, averaging about 20% compared to approximately 60 to 90% for other penicillins. ampicillin for injection is well tolerated by most patients and has been given in doses of 2 grams daily for many weeks without adverse reactions. microbiology while in vitro studies have demonstrated the susceptibility of most stra
ins of the following organisms, clinical efficacy for infections other than those included in the indications and usage section has not been demonstrated. antibacterial activity the following bacteria have been shown in in vitro studies to be susceptible to ampicillin for injection: gram-positive bacteria hemolytic and nonhemolytic streptococci streptococcus pneumoniae nonpenicillinase-producing staphylococci clostridium spp. b. anthracis listeria monocytogenes most strains of enterococci. gram-negative bacteria h. influenzae n. gonorrhoeae n. meningitidis proteus mirabilis many strains of salmonella , shigella , and e. coli. ampicillin does not resist destruction by penicillinase. susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, and impairment of fertility no long-term animal studies have been conducted with this drug.

How Supplied:

How supplied ampicillin for injection, usp for intramuscular or intravenous injection. ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram, or 2 grams ampicillin per vial. ndc 0781-9242-95 250 mg vial packaged in 10s ndc 0781-9250-95 500 mg vial packaged in 10s ndc 0781-9261-95 1 gram vial packaged in 10s ndc 0781-9273-95 2 gram vial packaged in 10s storage store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect the constituted solution from freezing. clinitest is a registered trademark of miles, inc. clinistix is a registered trademark of bayer corporation. tes-tape is a registered trademark of eli lilly company. premierprorx ® is a registered trademark of premier healthcare alliance, l.p., used under license. manufactured by sandoz gmbh for sandoz inc., princeton, nj 08540 revised: august 2020 46275232

Information for Patients:

Information for patients patients should be counseled that antibacterial drugs including ampicillin should only be used to treat bacterial infections. they do not treat viral infections (e.g., the common cold). when ampicillin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ampicillin or other antibacterial drugs in the future. diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having ta
ken the last dose of the antibiotic. if this occurs, patients should contact their physician as soon as possible.

Package Label Principal Display Panel:

250 mg label ndc 0781- 9242-95 ampicillin for injection, usp 250 mg per vial case qty.: 10 vials rx only store the dry powder at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. premier pro rx ® 250-mg-case-label

500 mg label ndc 0781- 9250-95 ampicillin for injection, usp 500 mg per vial case qty.: 10 vials rx only store the dry powder at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. premier pro rx ® 500-mg-case-label

1 gram label ndc 0781- 9261-95 ampicillin for injection, usp 1 gram per vial case qty.: 10 vials rx only store the dry powder at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. premier pro rx ® 1-gram-case-label

2 gram label ndc 0781- 9273-95 ampicillin for injection, usp 2 grams per vial case qty.: 10 vials rx only store the dry powder at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. premier pro rx ® 2-grams-case-label


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